Pharmaceutical companies spend millions of pounds every year making sure that the products they research, develop and manufacture meet GMP requirements. Possible harmful interactions are reduced through testing APIs or Active Pharmaceutical Ingredients. There are also strict regulations governing the clinical trials which the medicines and devices are put through before being released for public use. All of these efforts are to reduce the risk that the drugs pose to human patients when used.
However, the packaging and distribution of the drugs and medical devices is equally important as their quality and safety can be affected during transportation and storage. An ISO or International Organization of Standardization certificate is one of the highest awards of packaging quality that a pharmaceutical company can achieve. For this particular area of the pharmaceutical industry, an ISO 15378:2006 would be awarded.
Recently an ISO certificate was granted to a pharmaceutical packing company in Ireland and it was the first company in the country to receive one. Catalent’s Printed Components Plant gained the ISO certificate after a twelve month modification of its procedures.GMP training was given to all staff members and adaptations were made to the operating procedures and quality manual to achieve ISO/GMP standard procedures. It was confirmed that Catalent met GMP/ISO standards after a 5 day audit which assessed their whole production line.
The ISO 15378 is industry specific and only applies to packaging for pharmaceutical products in relation to the ISO 9001:2000. The customer requirements which factor in International and Regulatory Standards must be constantly met before a producer is granted the certificate. ISO 9001focuses on quality management systems that should be implemented in all organizations no matter what their industry, so they are not specific to the pharmaceutical industry.
GMP training is needed to implement proper packaging processes where medicinal products are in question. They are the only way to ensure that safer medicines are not made harmful during the distribution and storage stages.
Tags: gmp regulations, GMP training, pharmaceutical industry
